Advisory Committee Meeting to Focus on OPQ Priorities

Regulatory NewsRegulatory News | 14 August 2018 |  By 

The Pharmaceutical Science and Clinical Pharmacology Advisory Committee will meet on 20 September to discuss two topics related to the Office of Pharmaceutical Quality’s (OPQ) priority of promoting better medicine.

During the morning session of the meeting, the committee will discuss the modernization of assessing drug applications through a Knowledge-Aided Assessment and Structured Application (KASA) initiative.

“FDA will seek input on the potential enhancement of a submission format consistent with KASA to improve the efficiency and consistency of regulatory quality assessment,” according to a Federal Register notice posted Tuesday.

OPQ previously developed and piloted a dashboard interface related to KASA that focused on quality risks for critical quality attributes and corresponding mitigation strategies, as well as control strategies for drug substance and drug product.

The office also designed a computer-aided interface to emphasize lifecycle knowledge management and standardization of abbreviated new drug application (ANDA) quality assessment.

During the afternoon session, the committee will discuss “in-vitro/in-vivo relationship standards, and will seek input on establishing patient-focused dissolution standards for oral solid modified-release dosage forms.”

Comments received on or before 5 September will be provided to the committee, FDA said.

Federal Register


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